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Trial Title:
Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy
NCT ID:
NCT06093971
Condition:
Prostate Tumor
Conditions: Official terms:
Prostatic Neoplasms
Propofol
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
remimazolam
Description:
Remimazolam is administered for anesthesia induction.
Arm group label:
Group remimazolam
Intervention type:
Drug
Intervention name:
Propofol
Description:
Propofol is administered for anesthesia induction.
Arm group label:
Group propofol
Summary:
The investigators conduct a random assignment into either the remimazolam group or the
propofol group. Depending on the group assignment, either remimazolam (0.2 mg/kg) or
propofol (1.0 mg/kg) is administered. If necessary, additional doses of remimazolam (0.1
mg/kg) or propofol (0.5 mg/kg) are given. The standard anesthesia procedure of our
institution is followed, and blood pressure data recorded during the surgery is analyzed
(mean arterial pressure <65mmHg is defined as hypotension).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Patients who undergo robot-assisted laparoscopic prostatectomy and who have taken
renin-angiotensin system blockers for more than 3 months.
Exclusion Criteria:
1. emergency surgery
2. If the subject includes those who cannot read the consent form (e.g. illiterate,
foreigners, etc.)
3. cognitive dysfunction
4. Atrial fibrillation, moderate to severe valvular disease, ejection fraction of 35%
or less
5. Patients who did not take renin-angiotensin system blockers on the day of surgery
Gender:
Male
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yonsei University College of Medicine
Address:
City:
Seoul
Country:
Korea, Republic of
Contact:
Last name:
So Yeon Kim
Phone:
82-2-2228-2429
Email:
KIMSY326@yuhs.ac
Start date:
November 2023
Completion date:
September 2025
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06093971
